JP2017507762A - 送風/充填/シール装置用滅菌システム - Google Patents
送風/充填/シール装置用滅菌システム Download PDFInfo
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- JP2017507762A JP2017507762A JP2016565124A JP2016565124A JP2017507762A JP 2017507762 A JP2017507762 A JP 2017507762A JP 2016565124 A JP2016565124 A JP 2016565124A JP 2016565124 A JP2016565124 A JP 2016565124A JP 2017507762 A JP2017507762 A JP 2017507762A
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- Prior art keywords
- sterilization
- gas
- filling assembly
- blower
- sterilizing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
- B29C49/04—Extrusion blow-moulding
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/4273—Auxiliary operations after the blow-moulding operation not otherwise provided for
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/46—Component parts, details or accessories; Auxiliary operations characterised by using particular environment or blow fluids other than air
-
- C—CHEMISTRY; METALLURGY
- C01—INORGANIC CHEMISTRY
- C01B—NON-METALLIC ELEMENTS; COMPOUNDS THEREOF; METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C
- C01B21/00—Nitrogen; Compounds thereof
- C01B21/20—Nitrogen oxides; Oxyacids of nitrogen; Salts thereof
- C01B21/36—Nitrogen dioxide (NO2, N2O4)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/23—Containers, e.g. vials, bottles, syringes, mail
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/46—Component parts, details or accessories; Auxiliary operations characterised by using particular environment or blow fluids other than air
- B29C2049/4602—Blowing fluids
- B29C2049/4635—Blowing fluids being sterile
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/42403—Purging or cleaning the blow-moulding apparatus
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/4273—Auxiliary operations after the blow-moulding operation not otherwise provided for
- B29C49/42808—Filling the article
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B2210/00—Specific aspects of the packaging machine
- B65B2210/06—Sterilising or cleaning machinery or conduits
- B65B2210/08—Cleaning nozzles, funnels or guides through which articles are introduced into containers or wrappers
Landscapes
- Chemical & Material Sciences (AREA)
- Manufacturing & Machinery (AREA)
- Mechanical Engineering (AREA)
- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
Abstract
Description
Claims (16)
- 充填アセンブリを有する送風/充填/シール装置のための滅菌システムであって、
前記充填アセンブリを囲んでおり、かつプレナム、滅菌ガス入口及び滅菌ガス出口を形成している覆い部と、
前記滅菌ガス入口と、前記滅菌ガス出口との間の少なくとも1つの滅菌ガス流路を形成している外部配管と、
前記覆い部を通して前記滅菌ガスを循環させるために、前記滅菌ガス入口に隣接している、前記外部配管内に設けられた送風装置と、
前記送風装置と前記滅菌ガス入口との間の滅菌ガス流路内に設けられている、少なくとも1つの高効率粒子吸収(HEPA)フィルターと、
前記送風装置と制限された液体流路で接続されている滅菌ガス源とを備える、滅菌システム。 - 前記滅菌ガスが、二酸化窒素を含んでいる、請求項1に記載のシステム。
- 前記送風装置と前記HEPAフィルターとの間の前記外部配管に制限された流路で接続されている加湿配管をさらに有する、請求項1に記載のシステム。
- 前記外部配管に関連して設けられている湿度センサーをさらに有する、請求項1に記載のシステム。
- 前記外部配管に関連して設けられている滅菌剤濃度センサーをさらに有する、請求項1に記載のシステム。
- 前記送風装置の上流側で前記外部配管に制限された流路で接続されている洗浄空気配管をさらに有する、請求項1に記載のシステム。
- 前記覆い部に制限された流路で接続されている排気用配管をさらに有する、請求項1に記載のシステム。
- 前記排気用配管内に設けられた滅菌剤センサーをさらに有する、請求項1に記載のシステム。
- 前記覆い部に関連して設けられている圧力ゲージと、前記外部配管に関連して設けられている圧力ゲージとをさらに有する、請求項1に記載のシステム。
- 送風/充填/シール装置における充填アセンブリの滅菌方法であって、
滅菌ガス1リットル当たり、約10〜約20ミリグラムの二酸化窒素を含む前記滅菌ガスを供給するように、二酸化窒素と、相対湿度約50%〜約75%の加湿された空気とを組み合わせる工程と、
約18℃〜約30℃の範囲の温度で、少なくとも20分の時間期間の間、前記充填アセンブリを前記滅菌ガスに接触させる工程と、
次に、少なくとも65℃の温度で、少なくとも20分間、空気により充填アセンブリを洗浄し、残留二酸化窒素を除去する工程とを備える、滅菌方法。 - 送風/充填/シール装置における充填アセンブリの滅菌方法であって、
少なくとも20分の時間期間の間、約50%〜約75%の範囲の相対湿度の加湿された二酸化窒素ガスに、前記充填アセンブリを接触させる、滅菌方法。 - 送風/充填/シール装置における充填アセンブリの滅菌方法であって、前記充填アセンブリに、加湿された空気と、1リットル当たり、約10〜約20ミリグラムの範囲の量の二酸化窒素とを含み、相対湿度が約50%〜約75%である滅菌ガスを、少なくとも20分の時間期間の間、接触させる工程を備える、滅菌方法。
- 前記充填アセンブリを、約20分〜約30分の時間期間の間、加湿された二酸化窒素と接触させる、請求項12に記載の方法。
- 前記充填アセンブリを、約18℃〜約30℃の範囲の温度で、加湿された二酸化窒素と接触させる、請求項12に記載の方法。
- 前記充填アセンブリを、周囲温度で、加湿された窒素ガスと接触させる、請求項12に記載の方法。
- 前記滅菌ガスを、前記充填アセンブリに接触させる前に、HEPAフィルターを通過させる、請求項12に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US201461929374P | 2014-01-20 | 2014-01-20 | |
US61/929,374 | 2014-01-20 | ||
PCT/US2015/011916 WO2015109282A1 (en) | 2014-01-20 | 2015-01-19 | Sterilization system for a blow/fill/seal machine |
Publications (2)
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JP2017507762A true JP2017507762A (ja) | 2017-03-23 |
JP6586427B2 JP6586427B2 (ja) | 2019-10-02 |
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JP2016565124A Active JP6586427B2 (ja) | 2014-01-20 | 2015-01-19 | 送風/充填/シール装置用滅菌システム |
Country Status (5)
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US (2) | US10335507B2 (ja) |
EP (1) | EP3096802B1 (ja) |
JP (1) | JP6586427B2 (ja) |
CN (2) | CN110772653A (ja) |
WO (1) | WO2015109282A1 (ja) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2018218013A2 (en) | 2017-05-24 | 2018-11-29 | Sio2 Medical Products, Inc. | Sterilizable pharmaceutical package for ophthalmic formulations |
CN114617999A (zh) | 2017-03-27 | 2022-06-14 | 里珍纳龙药品有限公司 | 灭菌方法 |
EP3630043A1 (en) | 2017-05-24 | 2020-04-08 | Formycon AG | Sterilizable pre-filled pharmaceutical packages comprising a liquid formulation of a vegf-antagonist |
DE102018110036A1 (de) * | 2018-04-26 | 2019-10-31 | Krones Ag | Sterilisierbare Blasluftwege und Reckstange einer Blasmaschine |
US10961003B2 (en) * | 2018-06-07 | 2021-03-30 | Weiler Engineering, Inc. | Telescoping fill station shroud for a blow/fill/seal packaging machine |
MX2022002980A (es) * | 2019-09-16 | 2022-04-06 | Amgen Inc | Metodo para la esterilizacion externa de un dispositivo de suministro de farmacos. |
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2015
- 2015-01-19 EP EP15737850.6A patent/EP3096802B1/en active Active
- 2015-01-19 CN CN201911075047.3A patent/CN110772653A/zh active Pending
- 2015-01-19 JP JP2016565124A patent/JP6586427B2/ja active Active
- 2015-01-19 CN CN201580013361.2A patent/CN106102783B/zh active Active
- 2015-01-19 WO PCT/US2015/011916 patent/WO2015109282A1/en active Application Filing
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2016
- 2016-07-20 US US15/214,853 patent/US10335507B2/en active Active
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2019
- 2019-02-19 US US16/279,126 patent/US10532118B2/en active Active
Patent Citations (5)
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JPH10272173A (ja) * | 1996-12-12 | 1998-10-13 | Johnson & Johnson Prod Inc | 除染システムおよび除染方法 |
JP2001518816A (ja) * | 1997-04-08 | 2001-10-16 | ステリス コーポレイション | 一体化気相除染剤生成システムを備えた気相式除染アイソレーター装置 |
JP2004524085A (ja) * | 2001-02-16 | 2004-08-12 | ステリス インコーポレイテッド | 容器の蒸気相除染 |
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Also Published As
Publication number | Publication date |
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WO2015109282A1 (en) | 2015-07-23 |
CN110772653A (zh) | 2020-02-11 |
CN106102783A (zh) | 2016-11-09 |
US10532118B2 (en) | 2020-01-14 |
EP3096802B1 (en) | 2021-03-10 |
EP3096802A1 (en) | 2016-11-30 |
US20160324998A1 (en) | 2016-11-10 |
US10335507B2 (en) | 2019-07-02 |
US20190201567A1 (en) | 2019-07-04 |
EP3096802A4 (en) | 2017-10-04 |
CN106102783B (zh) | 2019-12-17 |
JP6586427B2 (ja) | 2019-10-02 |
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